NCT03070444

Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment

Completed NA Results posted Last updated 9 August 2022

What this trial tests

NA trial testing CTC retainer in Orthodontics in 104 participants. Completed in 18 June 2021.

Timeline

12 November 2009

Primary endpoint
14 January 2021

18 June 2021

Quick facts

Lead sponsor	Region Gävleborg
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	104
Start date	12 November 2009
Primary completion	14 January 2021
Estimated completion	18 June 2021

Drugs / interventions tested

• CTC retainer
• Essix retainer maxilla
• Essix retainer mandible
• Alginate impression
• Questionnaire

Conditions studied

• Orthodontics — all drugs for Orthodontics →
• Retention — all drugs for Retention →

Sponsor

Region Gävleborg — full company profile →

Who can join

Eligibility, any sex, with Orthodontics or Retention. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Changes in Tooth Position Primary · Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1)

Analyses of changes in tooth position on dental casts Little's Irregularity Index (in mm) 0=no crowding/irregularity, higher scores= more crowding/irregularity (worse outcome)

Group	Value	95% CI
Group A: CTC Retainer + Essix Retainer	0.05	-0.40 – 0.73
Group B: Essix Retainer + Essix Retainer	0.62	-0.08 – 1.49

Patients' Perception Secondary · T4 (5 years follow up)

Analyses of patients' perception by validated self-report questionnaires to evaluate experiences of the retention techniques VAS (visual analog scale, 0-100) 0= low satisfaction 100= high satisfaction

Group	Value	95% CI
Group A: CTC Retainer + Essix Retainer	93	79 – 98
Group B: Essix Retainer + Essix Retainer	92	69 – 96

Sponsor's own description

The purpose of this trial is to evaluate and compare stability after orthodontic treatment with an Essix retainer and a bonded cuspid-to-cuspid retainer (CTC), respectively in the mandibular arch and longitudinally follow these patients over time up to 5 years. The patients' perceptions of the two methods are also evaluated with questionnaires during the follow-up period.

A further aim of this study is to analyze the relationship between diagnosis, treatment outcome, treatment time, age at start of treatment and stability with an Essix retainer in the maxilla.

The null hypotheses are:

* that there is no difference in retention capacity between Essix retainer and cuspid-to-cuspid retainer
* that there is no difference in patients' perception between Essix retainer and cuspid-to-cuspid retainer
* that there is no difference in retention capacity for Essix retainer in the maxilla concerning diagnosis before treatment, treatment outcomes, treatment time and age at start of treatment

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vacuum-formed retainer versus bonded retainer for dental stabilization in the mandible-a randomized controlled trial. Part I: retentive capacity 6 and 18 months after orthodontic treatment.
   Krämer A, Sjöström M, Hallman M, Feldmann I. · · 2020 · cited 23× · PMID 31665279 · DOI 10.1093/ejo/cjz072
2. Vacuum-formed retainers and bonded retainers for dental stabilization-a randomized controlled trial. Part II: patients' perceptions 6 and 18 months after orthodontic treatment.
   Krämer A, Sjöström M, Hallman M, Feldmann I. · · 2021 · cited 14× · PMID 32613244 · DOI 10.1093/ejo/cjaa039
3. Post-treatment stability after 5 years of retention with vacuum-formed and bonded retainers-a randomized controlled trial.
   Krämer A, Sjöström M, Apelthun C, Hallman M, et al · · 2023 · cited 11× · PMID 35968668 · DOI 10.1093/ejo/cjac043
4. Which orthodontic retention protocol should I implement? A critical assessment of a randomised controlled trial.
   Steegmans PAJ, Cavagnetto D, Reynders RAM. · · 2022 · cited 2× · PMID 36526846 · DOI 10.1038/s41432-022-0845-7